IMPORTANCE OF COMMUNITY OF COLORS PARTICIPATING IN RESEARCH
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1 IMPORTANCE OF COMMUNITY OF COLORS PARTICIPATING IN RESEARCH Karriem S. Watson Adjunct Instructor DePaul College of Health Sciences Northwestern University School of Continuing Studies
2 IMPORTANCE OF PEOPLE OF COLOR PARTICIPATING IN RESEARCH Objectives 1. Review and understand the different types of research that takes place 2. Discuss the importance of diverse participating in clinical trials 3. Examine ways communities of color can be INFORMED about research
3 WHAT IS MEANT BY RESEARCH Clinical Trials: Phase I, II, III, IV Drugs Devices Procedures Observational Studies Chart reviews Questionnaires Qualitative Research Focus groups Surveys
4 CLINICAL TRIALS AND PHASES & TYPES Treatment Prevention Early detection/screening Diagnostic Quality of life/supportive care Phase I: Small, safety, few visits, LOTS of blood test Phase II: Larger, how drug works, safety Phase III: Large, how GOOD is drug/device Phase IV: Long term outcomes and safety
5 WHY SHOULD COMMUNITIES OF COLOR PARTICIPATE? HEALTH DISPARITIES African American adults 40% more likely to have high blood pressure Hispanic men and women HAVE HIGHEST LIFETIME RISK of developing diabetes than other ethnic groups.
6 WHAT HAPPENS WHEN COMMUNITIES OF COLOR DO NOT PARTICIPATE May not know how drugs work in particular communities (MANY factors play a role: race, genetics, & CULTURE) May not know RISKS of drugs in particular communities May not understand which treatments work BEST in one culture/community compared to others
7 WHY WE DO NOT PARTICIPATE? I don t want to be a guinea pig Lack of education about the process and value-added benefits of participation in clinical trials Lack of minority physicians (particularly those doing research) Negative experiences with health care system & MISTRUST
8 HISTORY : Tuskegee Experiment 1974 IRB Required 1994 NIH Guidelines on the inclusion of women and minorities in clinical trials 1997 FDA Modernization Act required FDA and NIH to consult on inclusion of women and minorities in clinical trials
9 Why we should all be concerned standard of care (What is it and Why important to me?) Product approvals (including those based on non-us data) Targeted therapies based on genetics (Especially true in Cancer Treatments & Screening ) Increasing evidence that race & ethnicity does matter in pharmacological treatment
10 Questions EVERY Patient Should ASK BEFORE taking any medications or treatment or RESEARCH Is the product safe? Is the product effective? Is the dose correct? Is this the best therapy? For me?... With approval of BiDil for the treatment of CHF in African American patients, the answer is YES!!!
11 EXAMPLE: BIDIL Drug for Heart Failure Original study in late 80 s and early 90s and study DID not include large percentage of blacks Original study results showed drug NOT effective.in Whites. BUT what about Blacks? New Study initiated 5/29/01 and terminated early on 7/19/04 because of significant survival benefit in the BiDil group1-3
12 HPV: CERVICAL CANCER AND WOMEN OF COLOR HPV strains that affect black women differ from those targeted by cancerpreventing vaccines, researchers say
13 WHEN PEOPLE OF COLOR DON T PARTICIPATE OR WHEN RACE IS NOT CONSIDERED The findings underscore the importance of having racial and ethnic minorities represented in clinical trials that result in new therapies and preventive treatments [There weren t] enough people of African descent, she said of the trials that led to Gardasil and Cervarix. We may be rethinking the vaccine itself. Cathrine Hoyo, MD: Duke University
14 WAYS COMMUNITIES CAN BE INFORMED Minority Community Perspective Become informed & consent to participate Pharmaceutical Industry Perspective Increasing minority participation in all clinical trials is good business FDA Perspective Mandate, mandate, mandate
15 WHAT YOU CAN DO IN CLINICS AND HEALTH CARE SETTINGS Understand that ANY drug, device or treatment that you are given as part of medical care has been approved through FDA approved research. BE able to identify MANDATES in place for research to PROTECT you (IRBs, Consent Forms, PI responsibility, LEGAL ACTIONS for misconduct) Participate (surveys, focus groups, phone interviews, TRIALS, particularly cancer trials)
16 WHAT YOU CAN DO IN COMMUNITY ENGAGED RESEARCH Identify what research is going on in your community Identify WHO is doing the research in your community Identify WHAT academic partners are doing research in your community Demonstrate to funders NEED for further/research about particular area that may be UNDERRESEARCHED in your community
17 TAKE HOME MESSAGE All treatment begins with research Its up to you to determine what role you will play in that research There are ALWAYS risks to research, even if minor The risks to NOT participating may be greater Not all research studies are for ALL people
18 QUESTIONS?????? Karriem S. Watson Clinicaltrials.gov olreview/irb/participant/studies.html
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